As discussed in Marion Nestle’s book, What to Eat, when preliminary evidence came out associating DHA–an omega-3 fatty acid–with visual and cognitive benefits in young infants, infant formula companies could not wait to begin adding it to their products.

The FDA approved the use of DHA in infant formula on the grounds that it is safe, and companies began selling formula with added DHA, charging a premium for the products and claiming they were better for babies based on the preliminary evidence.  And while FDA established the omega-3 fatty acid was a safe additive in infant formula, according to Nestle the agency did not require the companies to establish that DHA makes any difference in infant health after the first year.


infant-formula-featured.jpgAccording to the FDA Website, the agency does not approve infant formulas before the products can be marketed.  However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.


Companies now wanting to add other ingredients such as prebiotics, probiotics, lutein, lycopene, and betcarotene have evoked a response from the Center on Budget and Policy Priorities.  The Center, which conducts research and analysis to help shape public debates over proposed budget and tax policies and to help ensure that policymakers consider the needs of low-income families and individuals in these debates, has issued a report on the lack of evidence for the benefits of functional ingredients and the harm they will cause to the economic viability of the U.S. Department of Agriculture’s (USDA’s) assistance program for low income mothers and children, WIC.


About half of the infant formula sold each year in the U.S. is bought by the USDA for the WIC program.


The Center on Budget and Policy Priorities report says, “As pressure mounts to limit federal discretionary spending, it is critical to ensure that WIC not spend funds on foods with functional ingredients that do not deliver clinically significant benefits. WIC spent approximately $850 million on infant formula last year, and a recent USDA study found that more than ten percent of that spending ($91 million annually) is attributable to higher-priced formulas with functional ingredients.  Under current law, the additional cost to WIC of providing foods with these ingredients is likely to grow substantially as such foods proliferate.”


According to the report, formula manufacturers currently do not have to prove that the added ingredients that drive up the price do any good.  The Center on Budget and Policy Priorities stated:

“There is no mechanism within the national WIC program that requires USDA to review the research evidence on the claimed benefits of these functional ingredients or to base decisions about whether to offer foods containing such ingredients on their benefits and the specific needs of WIC participants. Currently, instead, infant formula manufacturers themselves decide whether WIC offers infant formulas with new functional ingredients, while state WIC programs decide whether WIC should offer other foods with such ingredients.”


The leading formula manufacturer, Mead Johnson, admits on its Enfamil Website* that some scientific studies have shown little or no benefit to infant development, lending support to the theory that the inclusion of these oils may just be a marketing gimmick.


“The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist,” according to the FDA’s Infant Formula-Q&A page.


As Nestle points out, “functional foods (and ingredients) are about marketing, not health.  If companies are going to add functional ingredients–and charge higher prices–they need to have some convincing scientific evidence to back up their claims.”



*According to Mead Johnson, manufacturer of Enfamil, studies that do not show functional benefits do not include formulas with at least 0.3% of the total fatty acids DHA.

  • jessica

    why doesn’t the usda spend more of that money they mark for infant formula on promoting breast feeding for mothers which is considered the perfect food that no “formula” has ever been able to duplicate and , oh, wait a minute, it’s free! What an incredible concept? I think young mothers who perhaps experience difficulty nursing just give up knowing that they can easily just toss together fake mother’s milk in a bottle and move on. Come on, USDA!

  • Michael Pescatore

    These DHA/ARA formulas have been causing serious digestive issues. The FDA has hundreds of reports from parents. The FDA is not enforcing its own rules that allow manufacturers to add DHA/ARA into infant formulas. DHA/ARA are Generally Regarded As Safe by the FDA. Long term side effects are unknown. Manufacturers are required to report side effects that are submitted by consumers to the FDA. Since 2002, not a single report has been submitted by manufacturers. The FDA has hundreds,possibly thousands of reports but suppresses this information from parents whom feed these formulas to their infants. These reports clearly show serious digestive issues that had been resolved when switched to a non DHA/ARA infant formula. The manufacturers have decided to discontinue production of non DHA/ARA infant formulas. They are aware that some infants may suffer but both the manufacturers and the FDA would rather make money. I have been fighting with the FDA for the past two years. They are aware of the serious safety concerns but protect manufacturers. Request adverse events reported for DHA/ARA infant formulas since 2002 from the Freedom of Information Act. I have, six seperate times. I have an incomplete account of 237 pages of adverse events. They still can’t seem to find my submissions. You will find that initial side effects that were revealed when manufacturers were applying for a GRAS status, have been harming infants for the past eight years.

  • Miranda

    DHA has been proven in several animal model and human studies to be necessary for neural development both during fetal development and through the first two years of life. I’m not sure about the evidence Michael is referring to, but perhaps the digestive issues were also a result of the poor digestibility of formula as a whole. As far as the report on adverse events – they submissions could be harmless or harmful, but any occurrence that may or may not be related to the study has to be accounted for. It does not necessarily mean there is a cause and effect relationship between the formula trial and the adverse event – saying the addition of essential fatty acids has been harming infants for years is a bit extreme.
    As for my own opinions, I find it deplorable that WIC encourages formula feeding by so freely giving it away to women who are entirely capable of breast feeding. For the very few who do have a need for formula (and I mean few), they should be provided with the top of the line products – with a doctor’s prescription. This need not cost millions of dollars. WIC promotes formula feeding and I have seen it with my own eyes. WIC’s efficiency quotas allow for such a brief interaction with each patient. The lactation consultants there are so limited by the time constraints and how WIC policy limits their ability to help. If you are lucky enough to be at a branch that has a lactation consultant, they may not even be able to spend enough time to identify the problem.